Recall Urged of Transvaginal Mesh and TVT Devices

FREE CASE EVALUATION: 1-800-632-1404

Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.  Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured.  For a free case evaluation, call 1-800-632-1404.

Pushing for a Recall

As an attorney who is representing women across the country and in Canada, I was intrigued by a series of articles on the push for a recall of these devices.  Summaries of these articles are:

Bloomberg News (8/26, Edney) reported that “Surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects,” according to Public Citizen, which said that the “products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence.” Public Citizen “estimates that 67,500 women” had the products “implanted last year,” and “the Food and Drug Administration received 1,503 reports of complications…from January 2008 to December 2010.”

The Minneapolis Star Tribune (8/26, Moore) reported that “FDA spokeswoman Karen Riley said the agency will ‘carefully review’ Public Citizen’s request,” and “will hold an advisory committee meeting in September.”  I recently posted a blog on the FDA meeting, which can be viewed by CLICKING HERE.

The AP reported on August 26 that the “FDA announced last month that complications with mesh are higher than previously estimated,” while “Public Citizen said mesh offers no benefit over traditional surgery with stitches.”

The Newark Star-Ledger also on August 26 explained that “nearly 300,000 women in the US had surgery to correct pelvic organ prolapse,” last year. It further pointed out that under “FDA’s controversial 510(k) program,” the material was not “required to be studied in patients” before being used. In response to complaints, last month, William Maisel, deputy director of the FDA’s Center for Devices and Radiological Health, issued a statement saying, “There are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse,” adding, “The FDA…is asking surgeons to carefully consider all other treatment options.”

Helping You

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.

If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible.

CALL: 1-800-632-1404

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